Tractography Pilot Study Leipzig

NCT ID: NCT04302857

Last Updated: 2022-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-12-31

Brief Summary

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In this pilot study participants will undergo routine magnetic resonance imaging and routine neurosurgical care. By prospectively collecting data from both MRI and patient records we want to investigate biomarkers derived from tractography and diffusion tensor imaging to predict rehabilitation potential.

Detailed Description

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Patients will undergo MRI before and after surgery with DTI. With CSD-tractography, fiber bundles and their volumes will be identified. By measuring fractional anisotropy (FA) within these volumes, a correlation with clinical outcome and recovery will be tested. Also, FA frequency distributions will be used to describe white matter integrity and to thereby improve future tractography algorithms. Fiber bundles of interest will be the arcuate fascicle (AF), the corticospinal tract (CST), frontal aslant tract (FAT), the inferior fronto-occipital fascicle (IFOF), the inferior longitudinal fascicle (ILF) and the uncinate fascicle (UF).

Conditions

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Intracranial Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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routine MRI

MRI with routine DTI sequence

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* intracranial lesion
* elective neurosurgical procedure

Exclusion Criteria

* MRI not applicable
* cerebral ischemia during study period
* pregnancy during study period
* encephalitis during study period
* spontaneous intracerebral hemorrhage during study period
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tim Wende

OTHER

Sponsor Role lead

Responsible Party

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Tim Wende

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jürgen Meixensberger, MD

Role: STUDY_CHAIR

University of Leipzig

Locations

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Leipzig University Hospital, Department of Neurosurgery

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

References

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Wende T, Hoffmann A, Scherlach C, Kasper J, Sander C, Arlt F, Dietel E, Stockert A, Meixensberger J, Prasse G. Preserved White Matter Integrity and Recovery After Brain Tumor Surgery: A Prospective Pilot Study on the Frontal Aslant Tract. Brain Connect. 2023 Dec;13(10):589-597. doi: 10.1089/brain.2023.0033. Epub 2023 Oct 19.

Reference Type DERIVED
PMID: 37646398 (View on PubMed)

Other Identifiers

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322/19-ek

Identifier Type: -

Identifier Source: org_study_id

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